{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "184278",
      "product_res_number": "Z-0494-2021",
      "event_date_initiated": "2020-10-12",
      "event_date_created": "2020-11-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-08-16",
      "res_event_number": "86666",
      "product_code": "OCL",
      "k_numbers": [
        "K123733"
      ],
      "product_description": "Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.",
      "code_info": "Model Number 60SF3, GTIN 00763000114626 Serial Numbers:  17420000, 17420001, 17420002, 17420003, 17420004, 17420005, 17420006, 17420007, 17420008, 17420009, 17420010, 17420013, 17420014, 17420015, 17420016, 17420017, 17420018, 17420019, 17420020, 17420022, 17420023, 17420024, 17420025, 17420026, 17420027, 17420028, 17420029, 18420000, 18420001, 18420002, 18420003, 18420004, 18420015, 18420016, 18420021, 18420022, 18420023, 18420024, 18420025, 18420026, 18420027, 19820016, 19820017, 19820018, 19820019, 19820020, 19820021, 19820022, 19820023, 19820024, 21020005, 22320038, 22320040, 22320041, 22320042, 22320043, 22320044",
      "firm_fei_number": "3008592544",
      "recalling_firm": "MEDTRONIC ATS MEDICAL, INC.",
      "address_1": "3800 Annapolis Ln N",
      "city": "Plymouth",
      "state": "MN",
      "postal_code": "55447-5439",
      "additional_info_contact": "Medtronic Customer Service\n800-854-3570",
      "reason_for_recall": "There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices",
      "root_cause_description": "Under Investigation by firm",
      "action": "In the United States (US), beginning 29-Oct-2020, a written Medical Device Correction letter will be mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification.  The letter requests the following actions:  \n- Identify and quarantine all unused CryoFlex Surgical Ablation devices as listed in the table below.\n- Return all unused affected product in your inventory to Medtronic.  Contact Medtronic Customer Service at 1-800-854-3570 to initiate a product return. Your local Medtronic Representative can assist you in the return of this product. \n- < Please complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. >\n- Please forward this notice to all those who need to be aware within your organization.",
      "product_quantity": "57 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.",
      "openfda": {
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        "fei_number": [
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        ],
        "device_name": "Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2"
      }
    }
  ]
}